A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00005110
• Other study ID #: NCRR-M01RR00036-5074
• Secondary ID: M01RR000036
• Status: Suspended
• Phase: N/A
• First received: April 13, 2000
• Last updated: June 23, 2005

Study information

• Verified date: November 2001
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function and symptoms. This study is investigating the long-term benefit of administration of the drug Salmeterol, a bronchodilator. Salmeterol will be compared to albuterol or placebo. The medication will be inhaled twice a day for 6 months.

Description:

Patients that have been diagnosed with cystic fibrosis and are above 5 years and below 45 years of age are eligible. Subjects will be randomized into 1 of 3 groups. One group will get Salmeterol by multi-dose inhaler (MDI) 2 puffs 2 times a day, one group will get albuterol by MDI 2 puffs 2 times a day and the other will get placebo by MDI 2 puffs 2 times a day. Height and weight along with pulmonary function testing and vital signs will be monitored at the beginning of the study and at Visits 2, 3, and 4. Peak flow monitoring will be done each morning before study medication at home. A daily diary will be kept of this measurement. Subjects will be seen in the research center at visits 1,2,3, and 4. Telephone contact will be done at Day 15, 60, 120, and 150. Individual outcomes include a potential increase in pulmonary function testing and a decrease in frequency of pulmonary exacerbations, hospitalizations, and usage of antibiotics.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 45 Years

Eligibility

Inclusion Criteria:

• Ability to perform reproducible spirometry

• FEVI > 50% and < 90% (Knudsen)

• A CF pulmonary exacerbation within the last year or an FEVI<80%

• At least one delta f508 allele on CF mutation analysis

• Ability to demonstrate use of inhaled medicine and FEVI and PEFR monitor

• Written informed consent

• Negative serum pregnancy test on enrollment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Salmeterol

• Albuterol

Locations

Country	Name	City	State
United States	Division of Allergy and Pulmonary Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States,